Senior Quality SpecialistApply
Locations: Dublin, Ireland - Hybrid
Time Type: Full time
Posted on: Posted 30+ Days Ago
Job Requisition ID: R001564
Why Endo? We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration, and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable, and inclusive workplace, and we are looking for talented individuals to join our team.
Job Description Summary The Senior Quality Specialist, Quality Operations leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities. Provides quality guidance on product transfers and validations and will ensure that all activities related to the manufacturing, packaging testing, release, and distribution of commercial products meet requirements in the U.S. market and other approved markets. Supports implementation and/or recommends internal/external business or compliance options and best practices to improve products, processes, or services. Assists with all aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events. Assists in decision making that requires developing options to solve moderate to complex issues. May lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures.
Key Accountabilities Quality Documentation/Reports ReviewContributes to preparation and/or review of annual product review and updates for regulatory filing(s), batch release metrics, and department reporting as applicable.Assists with decisions that require developing options to solve moderate to complex issues.Supports implementation and/or recommends internal/external business or compliance options and best practices to improve products, processes, or services.Prepares and/or reviews controlled documents (e.g. SOPs) required for compliance.Provides quality guidance on product transfers and validations and will ensure that all activities related to the manufacturing, packaging testing, release, and distribution of commercial products meet requirements in the U.S. market and other approved markets.Quality Systems & InvestigationsTakes the lead in resolving investigations, deviations, and corrective actions, and other quality issues with each CMO.Leads an individual system and assists in managing the Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities.Contributes to and may lead operational teams in the development, management, harmonization, and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations, and company quality standards in support of cGxP activities.Assists with all aspects of quality systems, such as Change Control, Deviations, Investigations, and CAPA systems to assure compliance and timely and accurate completion of reported events.Inspection ReadinessParticipates in cross-functional teams in preparation for regulatory inspections, quality and technical agreements, internal and external auditing, validation activities, and special projects.Qualifications Bachelor's degree in a scientific related field with a minimum of 5-8 years' relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry.Master's degree in above fields with 3-6 years' relevant experience in a pharmaceutical, biopharmaceutical, or sciences industry ORTechnical and quality background related to the sciences.Background in sterile manufacturing 1-5 years.Knowledge Strong knowledge of all current state, federal, and local US and EU standards and regulations (ICH, EU GMPs, US CFRs, ISO, etc.).Knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines.Strong knowledge of the principles, concepts, and theories of the compliance/QA discipline.Skills and Abilities Strong verbal and communication skills required.Attention to detail required.Demonstrated excellent interpersonal skills and flexibility.Ability to handle multiple priorities in a fast-paced environment.Good writing skills.Strong organizational skills.Ability to build peer relationships.Physical Requirements Routine office work (sit/stand).International Business travel up to 20%.Commitment to Diversity, Equity, and Inclusion: At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
About UsBe the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.
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